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Omniflex Diaphragm

Coopersurgical, Inc. · Model MXWF65 · UDI-DI 00888937001020

HDW Prescription
1
510(k) clearances
44
Adverse events
3
Recalls
3
Facilities

Description

Wide-Seal Silicone Vaginal Diaphragm, Size 65

Recalls

DateFirmReason
2016-02-16CooperSurgical, Inc.The products have been identified to contain an incorrect size Diaphragm.
2015-05-20CooperSurgical, Inc.A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
2013-02-26Cooper Surgical, Inc.Incorrect size was printed on the outer product packaging.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.